Gefitinib monotherapy in advanced non-small cell lung cancer: experience from a large, Western community, implementation study

¹ Univ. Hospital, Catholic University, Leuven
² Citadelle Hospital, Liège
³ Jules Bordet Institute, Brussels
⁴ Univ. Hopsital VUB, Brussels
⁵ St-Elisabeth Hospital, Namur
⁶ St-Andries Hospital, Tielt
⁷ Cliniques Universitaires St.-Luc, Brussels
⁸ Notre Dame Hospital, Charleroi
⁹ Univ. Hospital UCL, Yvoir
¹⁰ Middelheim Hospital, Antwerp
¹¹ Univ. Hospital UIA, Antwerp
¹² Astra Zeneca Medical, Brussels

^* To whom correspondence should be addressed. E-mail: johan.vansteenkiste{at}uz.kuleuven.ac.be.

	Abstract

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKI's) represent a new treatment option for patients with advanced NSCLC. This retrospective study examined to what extent previous clinical trial experience matches large-scale Western community implementation of this treatment.

In the Belgian expanded access programme, the data of 513 patients with advanced or metastatic NSCLC, not suitable for further chemotherapy and receiving oral gefitinib 250 mg·day^-1 until disease progression, death or unacceptable toxicity, were analysed.

Median duration of gefitinib treatment was 2.3 months (range 0.0-32.7). Use was predominantly in second- or third-line treatment. The overall response and disease control rates were 8.9% and 41.2%, respectively. In univariate analysis response was more common in females (P=0.002) and never-smokers (P=0.009). In multivariate analysis female gender was the only significant predictive factor (OR 0.329, 95%CI 0.129-0.839, P=0.020). Symptom improvement was reported in 108 patients of whom 32 (29.6%) had an objective response, 66 (61.1%) experienced disease stabilisation and 10 (9.3%) progressed. Gefitinib was well tolerated, only 7.8% of the patients reported grade 3 or 4 toxicity. Overall median survival was 4.7 months, with a 1-year survival of 21%. Survival was strongly influenced by a better performance status (PS) (good PS: HR 0.110, 95%CI 0.077-0.157, P<0.0001) and adenocarcinoma with bronchioloalveolar carcinoma features (AD/BAC) histology (HR 0.483, 95%CI 0.279-0.834, P=0.009).

The activity of gefitinib was confirmed in this large Western community implementation study. Response, present in a small subgroup, led to a rewarding survival and could be predicted by gender only. Baseline PS and AD/BAC histology were significant factors for survival.

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